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Clinical Trials associated with BAY-3389934 / Not yet recruitingPhase 1 First in Patient, Dose Escalation, Open Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Infusion of BAY 3389934 to Patients with Sepsis Induced Coagulopathy
Researchers are looking for a better way to treat people who have sepsis induced coagulopathy.
Sepsis happens when bacteria and their toxins spread in the blood, causing an infection. To overcome the infection the body responds activating the immune system, sometimes this immune response is too active and causes uncontrolled blood clot formation, also called sepsis-induced coagulopathy. Sepsis coagulopathy damages blood vessels and organs and leads to low platelet levels in the body. In severe cases, it can even lead to death.
The main purpose of this first in human study is to learn about how safe BAY 3389934 is, its suitable dose, and how it affects the participants with sepsis induced coagulopathy. For this study, researchers will enroll people receiving treatment for sepsis induced coagulopathy in a hospital intensive care unit (ICU).
For this, the researchers will collect the number of participants with medical problems during and after receiving BAY 3389934. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments.
Participants will be equally divided into different groups. The first group will receive the lowest dose of BAY 3389934. If researchers consider this dose to be safe, the next group of participants will receive a higher dose until the researchers find a suitable dose of BAY 3389934.
Each participant will be in the study for around 28 days. During the study, the doctors and their study team will:
* Take blood and urine samples,
* Do physical examinations,
* Check vital signs such as body temperature, blood pressure and heart rate,
* Examine heart health using electrocardiogram (ECG)
100 Clinical Results associated with BAY-3389934
100 Translational Medicine associated with BAY-3389934
100 Patents (Medical) associated with BAY-3389934
100 Deals associated with BAY-3389934